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Clinical Trials/NCT03101228
NCT03101228
Completed
Not Applicable

Medical and Physiological Benefits and Mechanisms of Reduced Sitting Without Meeting the Current Physical Activity Recommendations

Turku University Hospital1 site in 1 country64 target enrollmentApril 25, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic Syndrome
Sponsor
Turku University Hospital
Enrollment
64
Locations
1
Primary Endpoint
The change in whole-body insulin sensitivity
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The most important objective of this randomized controlled trial in subjects with increased cardiovascular and metabolic risk factors is to investigate whether only reduced daily sitting improves human cardiovascular and metabolic health during a six-month intervention. It is hypothesized and expected that only reduced sitting, without formal physical activity or exercise training, affects favorably cardiovascular and metabolic health.

Registry
clinicaltrials.gov
Start Date
April 25, 2017
End Date
March 4, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ilkka Heinonen

Principal Investigator

University of Turku

Eligibility Criteria

Inclusion Criteria

  • Physically inactive (less than 120 minutes of moderate intensity exercise per week measured by the activity monitor during run-in)
  • Sitting time ≥ 10 h /day (measured by the activity monitor during run-in)
  • BMI 25-40
  • Blood pressure \< 160/100 mmHg
  • Fasting plasma glucose \< 7.0 mmol/l
  • Fulfills the criteria of the metabolic syndrome according to Alberti et al 2009

Exclusion Criteria

  • History of a cardiac event
  • Insulin or medically treated diabetes
  • Any chronic disease or condition that could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
  • Presence of ferromagnetic objects that would make MR imaging contraindicated
  • Abundant use of alcohol
  • Use of narcotics
  • Smoking of tobacco or consuming snuff tobacco
  • Diagnosed depressive or bipolar disorder
  • Previous PET imaging or considerable exposure to radiation

Outcomes

Primary Outcomes

The change in whole-body insulin sensitivity

Time Frame: The change from baseline to 6 months

M-value during the hyperinsulinemic euglycemic clamp

The change in skeletal muscle insulin-stimulated glucose uptake

Time Frame: The change from baseline to 6 months

Glucose uptake in the femoral muscles will be measured by positron emission tomography (PET) with \[18F\]-labelled fluoro-deoxy-glucose (FDG) tracer during hyperinsulinemic euglycemic clamp

Secondary Outcomes

  • The change in maximal oxygen uptake(The change from baseline to 6 months)
  • The change in plasma glucose(The change from baseline to 6 months)
  • daily hours spent physically active(through study completion, an average of 6 months)
  • The change in liver adiposity(The change from baseline to 6 months)
  • The change in body fat percentage(The change from baseline to 6 months)
  • The change in HbA1c(The change from baseline to 6 months)
  • daily sitting hours(through study completion, an average of 6 months)

Study Sites (1)

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